RetinaPhase 3NCT00451763
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
A Phase 3 study testing Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml) in people with Retina and Telangiectasis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia. In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Retina, Telangiectasis
- What is being tested?
- Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with idiopathic macular telangiectasia
- patient consent
Who cannot join
- heart attack or cerebrovascular attack
- previous treatment for others retinopathy
- media opacities that preclude visualization of the fundus
- inability to understands the implications of the protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation
Salvador, Estado de Bahia, 41253-190
About this study
Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia.
In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. Before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. Long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. Although newly reported treatment, by photodynamic therapy for neovascular membrane associated with Idiopathic Macular Telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.
The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of Idiopathic Macular Telangiectasia.
- Conditions
- Retina, Telangiectasis
- Being tested
- Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)
- Keywords
- Fovea centralis/pathology, Fundus oculi, Retinal neovascularization, Telangiectasis/diagnosis, Tomography, optical coherence, Vitreous Body/drug effects
- Medical subject headings
- Telangiectasis, Retinal Neovascularization, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Optical coherence tomography
Fluorescein angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Walter Y Takahashi, M.D., Study director, University of Sao PauloOtacilio O Maia Jr, M.D., Principal investigator, Sao Rafael Hospital, Monte Tabor Foudation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451763
- Sponsor's protocol ID
- 165/07
- Status last verified
- Mar 2007
- First submitted
- 21 Mar 2007
- Last updated
- 23 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maia OO Jr, Bonanomi MT, Takahashi WY, Nascimento VP, Takahashi BS. Intravitreal bevacizumab for foveal detachment in idiopathic perifoveal telangiectasia. Am J Ophthalmol. 2007 Aug;144(2):296-9. doi: 10.1016/j.ajo.2007.03.059.
PubMed 17659962
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
- ClinicalTrials.gov ID
- NCT00451763
- Acronym / sponsor ID
- 165/07
- Conditions
- Retina, Telangiectasis
- Keywords
- Fovea centralis/pathology, Fundus oculi, Retinal neovascularization, Telangiectasis/diagnosis, Tomography, optical coherence, Vitreous Body/drug effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia.
In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. Before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. Long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. Although newly reported treatment, by photodynamic therapy for neovascular membrane associated with Idiopathic Macular Telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.
The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of Idiopathic Macular Telangiectasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with idiopathic macular telangiectasia
- patient consent
Key exclusion criteria (4 listed)
- heart attack or cerebrovascular attack
- previous treatment for others retinopathy
- media opacities that preclude visualization of the fundus
- inability to understands the implications of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml) | Drug | – |
Primary outcome
Visual acuity
Optical coherence tomography
Fluorescein angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2008.
- Derived from this study: PubMed 17659962Maia OO Jr, Bonanomi MT, Takahashi WY, Nascimento VP, Takahashi BS. Intravitreal bevacizumab for foveal detachment in idiopathic perifoveal telangiectasia. Am J Ophthalmol. 2007 Aug;144(2):296-9. doi: 10.1016/j.ajo.2007.03.059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Y Takahashi, M.D. study director
University of Sao Paulo
Otacilio O Maia Jr, M.D. principal investigator
Sao Rafael Hospital, Monte Tabor Foudation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml) in people with Retina and Telangiectasis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2008.